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About the Regulatory Profession

The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.

Regulatory Code of Ethics

One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.

Regulatory Competency Framework

Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.

Regulatory Convergence

Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.

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The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.

One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.

Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.

Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.

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FDA Releases 105 Product-Specific Guidances

Editor's Note: This article has been updated to correct the number of product-specific guidances released in this batch of documents.

The US Food and Drug Administration (FDA) on Thursday released 105 product-specific guidance documents to aid generic drug development, including 27 new draft guidances and 78 revised draft guidances.

The guidances, when finalized, are intended to promote generic competition by clarifying FDA’s expectations for the studies required to demonstrate that a generic drug is equivalent to a reference listed drug. So far, FDA has issued nearly 1,800 product-specific guidances.

As part of its commitments under the Generic Drug User Fee Amendments (GDUFA II) reauthorization, FDA committed to issuing product-specific guidances for 90% of non-complex new chemical entity new drug applications (NDAs) approved after 1 October 2017 at least two years ahead of the earliest abbreviated new drug application (ANDA) filing date. The agency also committed to issuing product-specific guidances for complex products “as soon as scientific recommendations are available.”

Most of the new draft guidances are for oral formulations, though a few are for ophthalmic, intravenous and subcutaneous formulations.

Most of the revised draft guidances are for topical and transdermal formulations, including extended release film formulations of estradiol, fentanyl and nicotine. In an email to Focus, FDA spokesperson Charles Kohler said that most of the revisions "are minor or editorial in nature, meant to ensure the PSGs are consistent, clear, up-to-date, and include links to the most current related guidances."